Breakthrough barriers: Seeking fast track review means betting on data says Roche

Breakthrough barriers: Seeking fast track review means betting on data says Roche

16-Apr-2015 - To benefit from breakthrough therapy designation (BTD) pharma companies must be willing “bet on the right data” according to Roche, which says this could be a challenge for smaller firms.

Expanded Catalent Pharma Solutions site in Winchester Kentucky

Catalent completes expansion of US complex tablet site

16-Apr-2015 - Catalent has doubled production capacity and added extra analytical lab space at its facility in Winchester, Kentucky, US.

BASF biggest player in solubility enhancement excipients sector

Big firms dominate solubility sector but demand creating space for small players, says Kline & Co

16-Apr-2015 - BASF, Abitec and Gattefossé dominate the solubility excipients market but growing demand for tech to enhance API solubility is creating opportunities for smaller suppliers according to new research.

Haemophilia is a blood-clotting disorder. (Image: Neal Fowler)

Bayer spends $100m on haemophilia development in Berkeley

16-Apr-2015 - Bayer has announced it will create a $100m (€94m) product testing site in California for its haemophilia A pipeline.

Climate change may let vector-borne diseases spread to UK

Concerns climate change will see tick-borne diseases spread to the UK are legitimate, says PHE

15-Apr-2015 - Concerns climate change will see malaria, West Nile virus and chikungunya spread to the UK are legitimate according to Public Health England, even though no insects carrying such diseases have been detected to date.

Recipharm invests in metal-linked API delivery tech in Synthonics deal

Recipharm invests in metal-linked API delivery tech in Synthonics deal

15-Apr-2015 - Recipharm has invested $2m (EUR1.8m) in metal co-ordinated chemistry (MCC) specialist Synthonics in a deal that will also see it help develop the US firm’s range of targeted drug products.

WHO HQ in Geneva, Switzerland - Organisation wants summary reports from  #Alltrials to be published

WHO: incentives and enforcement needed to improve trial data transparency

15-Apr-2015 - Publishing summary clinical trial results poses no threat to patient privacy according to the WHO, which says enforcing transparency laws and incentivising sponsors is key to making sure data from all trials is reported.

Pfizer vetting process sorts the strategic CMOs from the casual flings

Pfizer's vetting process sorts the strategic CMOs from the casual flings

15-Apr-2015 - Looking for a full-on partnership with Pfizer or a no-strings-attached manufacturing deal? Either way prepare for a tough screening process and don't be located too far from an airport.

A cure for HIV?

Abivax's ARV action could herald functional HIV cure, says firm

14-Apr-2015 - A drug candidate which prevents the export of viral RNA in infected cells could lead the way in developing a functional cure for HIV, according to Abivax.

WHO calls for Full trial disclosure

WHO says anything short of full trial disclosure skews public spending

14-Apr-2015 - Drug, vaccine and medical device developers should publish all trial results according to the WHO, which says anything less skews R&D priorities and public healthcare investment.

International convergence: Australia’s TGA proposes to adopt 10 EMA guidelines

International convergence: Australia’s TGA proposes to adopt 10 EMA guidelines

13-Apr-2015 - In a sign that pharmaceutical regulators are merging their regulations further, Australia’s TGA (Therapeutic Goods Administration) is seeking to adopt 10 EMA (European Medicines Agency) guidelines on quality, biologics, clinical efficacy, safety, and more.

Novo Nordisk pushes into Russia with new insulin manufacturing facility

Novo Nordisk pushes into Russia with new insulin manufacturing facility

13-Apr-2015 - Novo Nordisk has opened a new manufacturing facility in Russia for the formulation and filling of insulin as a diabetes treatment. 

Almac to move protein business to the Edinburgh Technopole business park

Almac to relocate protein business to up capacity and add new services

13-Apr-2015 - Almac will transfer its custom peptide manufacturing business to a site at the Edinburgh Technopole business park in Scotland’s capital in a £3.5m move designed to expand capacity.

Eisai inks R&D Genomics data deal; cuts 25% US jobs

Eisai inks R&D Genomics data deal; cuts 25% US jobs

13-Apr-2015 - Eisai has inked a deal with a genome analytics firm to aid drug discovery days after announcing it would be cutting 25% of its in-house US workforce.

Fines and product recalls in Taiwan over API concerns

API quality concerns prompt fines and drug recall orders in Taiwan

13-Apr-2015 - Thirteen Taiwanese drugmakers have been fined and ordered to recall products by regulators concerned the APIs they contain are food rather than pharma grade.

A $205 per share bid for Perrigo could see Mylan shilling out $29bn for Perrigo

My oh Mylan! $29bn Perrigo deal would create 'unrivalled' manufacturing network

09-Apr-2015 - Mylan has bid $29bn (€27bn) to buy Perrigo in what the firm says will create a company with “unrivalled” manufacturing and supply chain capabilities across OTCs, generics and APIs.

Industry must team to fight fakes says Rx-360

Fighting fake drugs about patient safety not competitive advantage says Rx-360

09-Apr-2015 - Fighting drug fakers relies on collaboration according to supply chain security group RX-360, which says drugmakers put rivalries on hold in the war against counterfeiters.

AI-based tech offers more accurate bioavailability predictions. (picture credit London Weekend Television)

Predicting oral bioavailability is better with AI says PharmaInformatic

09-Apr-2015 - Artificial intelligence can aid lead optimisation according to the German firm behind a new structure-based drug oral bioavailability prediction technology. 

Pfizer, Amgen’s Form 483s listed among more than 100 issued by US FDA already in 2015

Pfizer, Amgen’s Form 483s listed among more than 100 issued by US FDA already in 2015

08-Apr-2015 - Three Amgen manufacturing sites, along with Pfizer’s Perth, Australia site are part of a list of more than 100 US FDA Form 483s issued so far in 2015, according to a list obtained by In-Pharmatechnologist.com thanks to the FOIA (Freedom of Information Act) via the FDA.

Indian Government criticises France's ANSM 'evidence' of data manipulation at CRO GVK Bio

'Unjustified' ban of GVK-tested drugs has damaged India, says Pharmexcil

08-Apr-2015 - The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.